FDA Adverse Event Malfunction Summary report: N

VITALITY 2 DR IS-1/DF-1

MDR report key: 1683223 · Received May 7, 2010

Report

Report Number
2124215-2010-06491
Event Type
Malfunction
Date Received
May 7, 2010
Date of Event
March 15, 2010
Report Date
May 7, 2010
Manufacturer
GUIDANT CRM CLONMEL IRELAND
Product Code
LWS
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
INVALID DATA

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 VITALITY 2 DR IS-1/DF-1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165 NA

Patients

Seq Age Sex Outcome Treatment
1 67 YR